BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3850556 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-10118
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S SCS IPG WAS ALMOST DEPLETED FOLLOWING IMPLANT ((B)(6)). UPON HIS RELEASE, THE PT WAS PROVIDED INSTRUCTIONS REGARDING HOW TO CHARGE HIS IPG. THE PT REPORTED HE WAS ABLE TO FULLY CHARGE THE IPG; HOWEVER, THE IPG WAS DEPLETED AGAIN THE NEXT DAY. IT WAS NOTED THE PT DID NOT EXPERIENCE ANY DIFFICULTY ESTABLISHING COMMUNICATION BETWEEN THE IPG AND CHARGING SYSTEM. A REPLACEMENT CHARGING SYSTEM DID NOT RESOLVE THE ISSUE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE IPG TO ADDRESS THE REPORTED ISSUE. EFFECTIVE STIMULATION WAS ACHIEVED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317235 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 4087179

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other